Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bravo G4 Chamber Autoclave

K-Number: K210326 · 2021-07-01

ApplicantScican , Ltd.
Decision Date2021-07-01
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bravo G4 Chamber Autoclave is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K210326. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bravo G4 Chamber Autoclave?

Bravo G4 Chamber Autoclave is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Scican , Ltd.. The 510(k) number is K210326.

When did Bravo G4 Chamber Autoclave receive FDA 510(k) clearance?

Bravo G4 Chamber Autoclave received FDA 510(k) clearance on 2021-07-01, under 510(k) number K210326.

Who is the listed applicant for Bravo G4 Chamber Autoclave?

The FDA 510(k) record lists Scican , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bravo G4 Chamber Autoclave?

The FDA product code for Bravo G4 Chamber Autoclave is FLE.

Other records listing Scican , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214057STATIM 6000B Vacuum AutoclaveK192910STATClave G4 Chamber AutoclaveK190062STATCLAVE G4 Chamber AutoclaveK172292SALUS - Hygiene Instrument Reprocessing Container

Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑